Responsible Pharmacist and Regulatory Affairs Manager

Ensure company compliance to all legal and statutory requirements of the South African Pharmacy Council, the provisions of the Pharmacy Act No. 53 of 1974, the Medicines and Related Substances Control Act of 1953 and other legislation applicable to the scope of practice of a Responsible Pharmacist

Monitor, review and translate all regulatory requirements of the Medicines Regulatory Authority
Develop and implement strategies for earliest possible regulatory approvals to support business
Maintain good standing with industry regulators
Manage the regulatory department in line with company expectations

Responsibilities:

- Responsible Pharmacist – contemplated in regulation 25(3) of the Pharmacy Act and the relevant sections of the Medicines Act
- Regulatory affairs management
- Managing a team of regulatory affairs pharmacists and regulatory affairs assistants
- Pharmacovigilance
- Local manufacturing technical responsibilities
- Quality assurance and compliance
- Reporting and budgeting
- Training and support

Requirements:

- Bachelor of Pharmacy Degree
- Minimum 5 years’ experience in Regulatory Affairs with at least 2 years on a managerial level
- Responsible Pharmacist and production / quality assurance experience
- Thorough understanding of the laws and regulations governing registration of medicines in South Africa and SADC countries
- Highly PC literate
- Valid South African driver’s license and own reliable vehicle
- Clear criminal record and no bad credit

The following documents are required as part of your application process:

- Comprehensive CV in MS Word format
- South African ID and valid driver's license
- Qualification/s
- Most recent pay slip/s

If you have not had a response in two weeks, consider your application unsuccessful